Descripción y detalle de las actividades
Develops, institutes, and maintains the formal systems and procedures that are required for compliance to the Quality System/Good Manufacturing Practices regulations and other applicable regulatory requirements.
Holds the Quality Assurance responsibility for Harmac facility, maintaining a dotted line relationship with the President and CEO to assure compliance with all regulatory agencies as applicable.
Manages the Quality Assurance Department technical support functions for the company.
These functions include, but are not limited to: o Product reliability and performance studies o Product/process validating o Statistical data acquisition and analysis o Documentation of product inspection plans o Material biocompatibility testing and selection o Sterilization technical resources o Product complaint handling system o Internal audits o Related Quality engineering services Acts as a liaison with customer quality personnel and regulatory agencies such as the FDA, etc, to: o Acting as company liaison for all company/customer quality assurance audits.
o Developing strategy for compliance/certification to ISO standards.
o Developing vendor certification/qualification with the vendor rating system.
o Preparing department budget and that portion of the company's annual operating plan that pertains to the Quality Assurance function.
Analyzes, evaluates, and presents information concerning factors such as business situations, production capabilities, manufacturing problems, economic trends, and design and development of new products for consideration by other members of management team.
Suggests and debates alternative methods and procedures in solving problems and meeting changing market opportunities.
Negotiates with other top management personnel in formulating and establishing company policies, operating procedures, and goals.
Experiência y requisitos
**Número de vacantes** 1
**Área** Calidad
**Contrato** Permanente
**Modalidad** Presencial
**Turno** Diurno
**Jornada** Tiempo Completo
**Estudios** Carrera Profesional
**Sexo** Indistinto
**Disponibilidad p. viajar** Si